Covering the whole development process for the global biotechnology industry

Bioprocessing begins upstream, most often with culturing of animal or microbial cells in a range of vessel types (such as bags or stirred tanks) using different controlled feeding, aerating, and process strategies.

Beginning with harvest of material from a bioreactor, downstream processing removes or reduces contaminants to acceptable levels through several steps that typically include centrifugation, filtration, and/or chromatographic technologies.

Drug products combine active pharmaceutical ingredients with excipients in a final formulation for delivery to patients in liquid or lyophilized (freeze-dried) packaged forms — with the latter requiring reconstitution in the clinical setting.

Many technologies are used to characterize biological products, manufacturing processes, and raw materials. The number of options and applications is growing every day — with quality by design (QbD) giving impetus to this expansion.

Even as it matures, the biopharmaceutical industry is still a highly entrepreneurial one. Partnerships of many kinds — from outsourcing to licensing agreements to consultancies — help companies navigate this increasingly global business environment.

September 2011 Supplement

New methods and platforms for rapid development and production of effective subunit vaccines have become a 21st-century imperative. Not only is it important to rapidly express and produce a large number of antigens, but those antigens must be expressed and folded such that their effectiveness in preclinical studies is predictive of their potential effectiveness as vaccines. This task has created a bottleneck in vaccine development because recombinant protein expression is difficult and time-consuming, involving a large number of variables. Highly…

Significant changes are sweeping the vaccine manufacturing industry. Demand for human vaccines is predicted to grow significantly — in part driven by needs in emerging countries, where only small fractions of their large and growing populations has access to vaccines. Sustained growth is expected to yield a vaccine market of US$25 billion by the year 2015 (1). Relatively low immunization rates in the Asia–Pacific regions represent significant untapped potential for vaccine manufacturers. Growing populations, increased government funding, and increasing personal…

A novel influenza A (H1N1) virus was discovered in Mexico in early 2009 (1). Infections from this strain led to declaration of a pandemic midyear, with about 61 million patients and 13,000 deaths reported by the US Centers for Disease Control (2). Although the pandemic officially ended in August 2010 (3), vaccines are still in demand to protect people against the H1N1 strain that is now expected to circulate seasonally for years to come. To best respond to…

On 28 June 2011, the Food and Agriculture Organization of the United Nations declared the Rinderpest cattle plague virus to be the second troublesome virus (after smallpox) that humans have eradicated from the Earth (1). Such achievements herald exciting times both for classical vaccinology and for many new and developing technologies. Here we consider scaling up of vaccines and related hybrid, targeted, and conjugated viral therapeutics that are made through animal cell culture. The vaccine industry is now…

Seasonal influenza affects millions of people around the world, with as many as 500,000 deaths annually resulting from influenza-related illnesses. The flu virus undergoes frequent and unpredictable mutations (antigenic drift and shift) that limit the ability of available strain-specific vaccines to protect the population against strains other than those specifically included in a particular season’s flue vaccine. Annual reformulation of the vaccines is needed for annual immunizations. BiondVax Pharmaceuticals Ltd., an Israeli biotechnology company, is developing a universal…

Picture rows and rows of chicken eggs incubating not to hatch chickens, but to produce vaccines. With the exception of a few products on the market now, most vaccines are still made using this 50-year-old technology. Using chicken eggs to produce vaccines takes about half a year to complete and requires on average one to two eggs to make a single vaccine dose. It is inefficient, labor intensive, time consuming, and subject to contamination. The latter may be…

Vaccines represent one of the most important medical developments in human history. As recently as a century ago, infectious diseases were the main cause of death worldwide, even in the most developed countries. For instance, the Spanish flu pandemic of 1918 killed more people than all the bullets and bombs did during World War I (1). Today, a vast range of vaccines are available to protect against more than two dozen infectious diseases, especially in pediatrics. Our society…

Conference themes and approaches can be looked at as sort of a crazy quilt representing the state of the industry: with pieces of all different shapes and colors that come together to form a cohesive whole. They fit together in many ways, depending on the organizers (quilters?); many pieces are omitted and saved for the next quilt. But how to find the most successful combinations requires technique as well as imagination. Here are some topics I’ve been…

In the early spring of 2009, a new strain of H1N1 influenza emerged and swept across the globe more rapidly than vaccine producers could keep pace. By the time the pandemic abated in February 2010, the US Centers for Disease Control (CDC) estimated that between 8,500 and 17,600 Americans had died from H1N1 infection, with a disproportionate number of deaths occurring among healthy children and young adults. An estimated 15–25% of the nation’s population was exposed to the…